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Access to EyeGlasses for School-aged Children (ATEG)

Primary Purpose

Myopia, Amblyopia, Hyperopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fitz Frames 3-D Printed Glasses
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Masshealth insurance
  • first-time glasses wearers
  • receive a diagnosis of refractive amblyopia, myopia, hyperopia and/or astigmatism requiring spectacle correction for optimal vision at distance and near.
  • Glasses must be recommended for full time wear by the attending optometrist or ophthalmologist

Exclusion Criteria:

  • strabismus
  • developmental or learning delay
  • other ocular pathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Fitz Frames 3-D Printed Glasses

    Traditional Glasses Procurement Group

    Arm Description

    The intervention group will order glasses directly in the office following their exam and consent using an iPad with the help of the research assistant. The iPad will be e-connected to a 3D printed glasses manufacturer (Fitz Frames) through their application, allowing the child (with assistance from the doctor or research assistant) to take various measurements in real time. Sixteen different measurements will be taken including interpupillary distance, face length, face width, and temple measures. The child will be able to choose frame style and order it directly from the manufacturer immediately following the exam. Glasses will be shipped directly to the patient's home (shipping address will be input to the app by the family).

    (1) The control group will receive standard of care in which a prescription for glasses will be dispensed as a paper copy prescribed by the examiner before randomization. The research assistant will use a script (attached) that instructs families how to procure glasses traditionally through Masshealth. The participant/family will be instructed to bring the paper prescription to an optical shop that carries MassHealth frames. A printout of local optical shops that carry MassHealth frames will be provided to the patient.

    Outcomes

    Primary Outcome Measures

    Compliance
    Glasses compliance will be assessed with self-reported calendar
    Quality of Life Questionnaire
    Quality of life measures using the PedEyeQ
    Distance visual acuity
    Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
    Distance visual acuity
    Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
    Distance visual acuity
    Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
    Stereoacuity
    Stereo Fly test
    Stereoacuity
    Stereo Fly test
    Stereoacuity
    Stereo Fly test
    Ocular alignment
    Alternative prism cover test at distance and at near
    Ocular alignment
    Alternative prism cover test at distance and at near
    Ocular alignment
    Alternative prism cover test at distance and at near
    Near point of convergence
    Near point of convergence (break point and recovery) will be measured using an accommodative target
    Near point of convergence
    Near point of convergence (break point and recovery) will be measured using an accommodative target
    Near point of convergence
    Near point of convergence (break point and recovery) will be measured using an accommodative target
    Near visual acuity
    Near visual acuity will be measured at 40 cm using the Rosenbaum card
    Near visual acuity
    Near visual acuity will be measured at 40 cm using the Rosenbaum card
    Near visual acuity
    Near visual acuity will be measured at 40 cm using the Rosenbaum card
    Quality of Life Questionnaire- PedEyeQ
    Quality of life measures using the PedEyeQ
    Quality of Life Questionnaire- PedEyeQ
    Quality of life measures using the PedEyeQ

    Secondary Outcome Measures

    Full Information

    First Posted
    October 3, 2022
    Last Updated
    January 9, 2023
    Sponsor
    Boston Children's Hospital
    Collaborators
    Fitz Frames, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05588362
    Brief Title
    Access to EyeGlasses for School-aged Children
    Acronym
    ATEG
    Official Title
    Access to EyeGlasses for School-aged Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Boston Children's Hospital
    Collaborators
    Fitz Frames, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Uncorrected refractive error is a leading cause of visual impairment in children and can impact vision, quality of life, and academic performance. Despite Boston Children's Hospital serving patients from a wide range of socioeconomic backgrounds, there are health disparities in access to eyeglasses as a consequence of patients' health insurance. The investigators will examine whether the use of an in-clinic app for 3-D printed glasses reduces disparities in access to eyeglasses for our patients on Medicaid. The intervention will address social determinants of health and improve pediatric health outcomes namely, how and when children having publicly funded health insurance receive eyeglasses. The short-term objectives are (1) to compare the time to receive glasses between publicly funded MassHealth eyeglasses and an in-clinic order of 3D printed glasses (2) to evaluate compliance with glasses wear in these two groups, and (3) to evaluate visual function and quality-of-life outcomes in these two groups. This prospective randomized control study will evaluate barriers to accessing eyeglasses in school-aged children. The investigators will recruit children enrolled in MassHealth and randomize them into two cohorts: (1) the control group will receive MassHealth glasses as per standard of care, through an optical shop of their choosing, or (2) the intervention group will use an app for immediately ordering glasses (paid for by the study) in clinic following their appointment. The investigators will evaluate the time needed to receive eyeglasses, compliance with glasses wear, quality of life, and visual outcomes between the cohorts at one-, three-, and six-month intervals. Through this project, the investigators will not only evaluate, quantify, and bring awareness to disparities in our patient population, but will also look toward finding a solution through the use of a novel application that addresses many of the barriers faced by patients insured through Medicaid.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Amblyopia, Hyperopia, Refractive Errors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective randomized control study
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Investigators responsible for administering questionnaires and collecting visual outcomes will be masked to the treatment group of the participant. Both the research assistant and participant will be unmasked.
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fitz Frames 3-D Printed Glasses
    Arm Type
    Experimental
    Arm Description
    The intervention group will order glasses directly in the office following their exam and consent using an iPad with the help of the research assistant. The iPad will be e-connected to a 3D printed glasses manufacturer (Fitz Frames) through their application, allowing the child (with assistance from the doctor or research assistant) to take various measurements in real time. Sixteen different measurements will be taken including interpupillary distance, face length, face width, and temple measures. The child will be able to choose frame style and order it directly from the manufacturer immediately following the exam. Glasses will be shipped directly to the patient's home (shipping address will be input to the app by the family).
    Arm Title
    Traditional Glasses Procurement Group
    Arm Type
    No Intervention
    Arm Description
    (1) The control group will receive standard of care in which a prescription for glasses will be dispensed as a paper copy prescribed by the examiner before randomization. The research assistant will use a script (attached) that instructs families how to procure glasses traditionally through Masshealth. The participant/family will be instructed to bring the paper prescription to an optical shop that carries MassHealth frames. A printout of local optical shops that carry MassHealth frames will be provided to the patient.
    Intervention Type
    Other
    Intervention Name(s)
    Fitz Frames 3-D Printed Glasses
    Intervention Description
    The intervention group will order glasses directly in the office following their exam and consent using an iPad with the help of the research assistant. The iPad will be e-connected to a 3D printed glasses manufacturer (Fitz Frames) through their application, allowing the child (with assistance from the doctor or research assistant) to take various measurements in real time. Sixteen different measurements will be taken including interpupillary distance, face length, face width, and temple measures. The child will be able to choose frame style and order it directly from the manufacturer immediately following the exam. Glasses will be shipped directly to the patient's home (shipping address will be input to the app by the family).
    Primary Outcome Measure Information:
    Title
    Compliance
    Description
    Glasses compliance will be assessed with self-reported calendar
    Time Frame
    Six months
    Title
    Quality of Life Questionnaire
    Description
    Quality of life measures using the PedEyeQ
    Time Frame
    Baseline, will be collected at enrollment visit
    Title
    Distance visual acuity
    Description
    Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
    Time Frame
    Baseline, will be collected at enrollment visit
    Title
    Distance visual acuity
    Description
    Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
    Time Frame
    0-3 Months, will be collected at 3 month visit
    Title
    Distance visual acuity
    Description
    Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
    Time Frame
    3-6 Months, will be collected at 6 month visit
    Title
    Stereoacuity
    Description
    Stereo Fly test
    Time Frame
    Baseline, will be collected at enrollment visit
    Title
    Stereoacuity
    Description
    Stereo Fly test
    Time Frame
    0-3 Months, will be collected at 3 month visit
    Title
    Stereoacuity
    Description
    Stereo Fly test
    Time Frame
    3-6 Months, will be collected at 6 month visit
    Title
    Ocular alignment
    Description
    Alternative prism cover test at distance and at near
    Time Frame
    Baseline, will be collected at enrollment visit
    Title
    Ocular alignment
    Description
    Alternative prism cover test at distance and at near
    Time Frame
    0-3 Months, will be collected at 3 month visit
    Title
    Ocular alignment
    Description
    Alternative prism cover test at distance and at near
    Time Frame
    3-6 Months, will be collected at 6 month visit
    Title
    Near point of convergence
    Description
    Near point of convergence (break point and recovery) will be measured using an accommodative target
    Time Frame
    Baseline, will be collected at enrollment visit
    Title
    Near point of convergence
    Description
    Near point of convergence (break point and recovery) will be measured using an accommodative target
    Time Frame
    0-3 Months, will be collected at 3 month visit
    Title
    Near point of convergence
    Description
    Near point of convergence (break point and recovery) will be measured using an accommodative target
    Time Frame
    3-6 Months, will be collected at 6 month visit
    Title
    Near visual acuity
    Description
    Near visual acuity will be measured at 40 cm using the Rosenbaum card
    Time Frame
    Baseline, will be collected at enrollment visit
    Title
    Near visual acuity
    Description
    Near visual acuity will be measured at 40 cm using the Rosenbaum card
    Time Frame
    0-3 Months, will be collected at 3 month visit
    Title
    Near visual acuity
    Description
    Near visual acuity will be measured at 40 cm using the Rosenbaum card
    Time Frame
    3-6 Months, will be collected at 6 month visit
    Title
    Quality of Life Questionnaire- PedEyeQ
    Description
    Quality of life measures using the PedEyeQ
    Time Frame
    0-3 Months, will be collected at 3 month visit
    Title
    Quality of Life Questionnaire- PedEyeQ
    Description
    Quality of life measures using the PedEyeQ
    Time Frame
    3-6 Months, will be collected at 6 month visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Masshealth insurance first-time glasses wearers receive a diagnosis of refractive amblyopia, myopia, hyperopia and/or astigmatism requiring spectacle correction for optimal vision at distance and near. Glasses must be recommended for full time wear by the attending optometrist or ophthalmologist Exclusion Criteria: strabismus developmental or learning delay other ocular pathology

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Access to EyeGlasses for School-aged Children

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